BIRMINGHAM HIP RESURFACING (BHR) 74121142Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 03596010502773), received between May 26, 2017 and Jun 30, 2025 — classified as 1 death, 56 injuries.

The most frequently reported specific device problem is “Biocompatibility” (27 reports).

29 other recalls cover devices cleared under the same FDA submission (P040033); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WITH A HISTORY OF COXARTHROSIS UNDERWENT A RIGHT BIRMINGHAM HIP RESURFACING (BHR) PROCEDURE ON (B)(6) 2007. APPROXIMATELY THREE MONTHS POST-IMPLANTATION, THE PATIENT EXPERIENCED A PROSTHETIC DISLOCATION. ALTHOUGH NO TREATMENT DETAILS WERE DOCUMENTED, LATER PHYSICIAN NOTES RAISED CONCERNS ABOUT IMPLANT POSITIONING, INCLUDING A 30° ACETABULAR ANTEVERSION, AND REPORTED PATIENT SYMPTOMS CONSISTENT WITH JOINT INSTABILITY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 22353252 ↗
• InjuryMay 9, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PLAINTIFF UNDERWENT A LEFT METAL-ON-METAL BHR PERFORMED ON (B)(6) 2012, HAS EXPERIENCED PAIN IN THE LEFT HIP SINCE. IT WAS RECOMMENDED TO HER TO UNDERGO A REVISION SURGERY DUE TO HER METALLOSIS AS WELL AS RADIOGRAPHIC FINDINGS AROUND FEMORAL COMPONENT. SHE STATES HER PAIN CONTINUES TO INCREASE. SHE HAS PAIN EVERYDAY PAIN THAT SIGNIFICANTLY LIMITS HER QUALITY OF LIFE AND LIMITS HER ACTIVITIES. ON (B)(6) 2024 SHE HAD COBALT AND CHROMIUM LEVELS DRAWN AND HER COBALT WAS 33.7. IN HER X-RAYS IT SEEMS LIKE THE ACETABULAR COMPONENT IS AN GOOD POSITION AND WELL FIXED. ON THE FEMORAL SIDE, THERE IS SCALLOPING AND OSTEOLYSIS AROUND THE FEMORAL COMPONENT AND FEMORAL NECK. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO METALLOSIS. THE ACETABULAR COMPONENT WAS RETAINED AND FEMORAL HEAD WAS REMOVED AND REPLACED WITH DUAL MOBILITY CONSTRUCT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOW.

  Patient problems: High metal ion levels; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 21993870 ↗
• InjuryJul 10, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT HIP RESURFACING (BHR) ON (B)(6) 2007 DUE TO OSTEOARTHRITIS, THE PATIENT PRESENTED PAIN, DISCOMFORT AND ELEVATED LEVELS OF COBALT/CHROMIUM IONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, IN WHICH BOTH RESURFACING COMPONENTS WERE EXPLANTED AND CONVERSION TO THA WAS CONDUCTED. EVEN THOUGH AN ACETABULAR BONE GRAFT WAS REQUIRED, THE COMPLICATING FACTOR WAS DETERMINED TO BE THE BHR HEAD. A CERAMIC FEMORAL HEAD AND AN ACETABULAR SHELL MULTI-HOLE WERE PLACED, ALONG WITH A POLY LINER AND A CEMENTLESS FEMORAL STEM (COMPETITOR'S DEVICES). THE PATIENT PRESENTED POST-OPERATIVE PAIN 7 WEEKS AFTER REVISION, FOR WHICH MEDICATIONS AND PHYSIOTHERAPY WERE RECOMMENDED. IT IS CURRENTLY UNKNOWN IF THIS CONDITION HAS IMPROVED.

  Patient problems: Arthralgia; High metal ion levels; Metal Related Pathology

  MAUDE report 19713617 ↗
• InjuryJul 9, 2024Migration; Migration

  IT WAS REPORTED THAT ON LITERATURE REVIEW ""CLINICAL AND RADIOGRAPHIC OUTCOMES OF THE BIRMINGHAM HIP RESURFACING ARTHROPLASTY AT A MINIMUM FOLLOW-UP OF 10 YEARS: RESULTS FROM AN INDEPENDENT CENTRE"", 1 (ONE) PATIENT SUFFERED FROM A VARUS FEMORAL COMPONENT SHIFT AND REQUIRED A REVISION SURGERY 18 MONTHS AFTER THE PRIMARY METAL-ON-METAL HIP RESURFACING PROCEDURE. DURING THE REVISION SURGERY, THE PRIMARY SYSTEM WAS EXPLANTED AND REPLACED BY AN UNSPECIFIED UNCEMENTED THA METAL-ON-POLYETHYLENE SYSTEM. THE PRIMARY SURGERY WAS A BHR METAL ON METAL DUE TO OSTEOARTHRITIS IN CONGENITAL HIP DYSPLASIA. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19705993 ↗
• InjuryJul 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, A PLAINTIFF RECEIVED A RIGHT BHR SYSTEM ON (B)(6) 2008. THEY LATER DEVELOPED SEVERE SHARP TYPE HIP PAIN, DIFFICULTY WITH DAILY ACTIVITIES, AND WERE DIAGNOSED WITH RIGHT FEMORAL IMPLANT LOOSENING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO EXCHANGE THE ACETABULAR AND FEMORAL BHR COMPONENTS FOR A BIOMET THA SYSTEM. PATIENT WAS EVENTUALLY DISCHARGED FROM OT AND PT IN GOOD CONDITION ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 19674769 ↗
• InjuryFeb 9, 2024Biocompatibility; Migration; Biocompatibility; Migration

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A RIGHT BIRMINGHAM HIP RESURFACING ON (B)(6) 2015 BECAUSE THE PATIENT SUFFERED A SEVERE DEGENERATIVE OSTEOARTHRITIS IN THE RIGHT HIP. THE PATIENT SUFFERED PROGRESSIVE AND DEBILITATING HIP PAIN SECONDARY TO METALLOSIS. CLINICAL AND RADIOGRAPHIC REVEALED EVIDENCE OF METALLOSIS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023. DURING SURGERY, IT WAS NOTICED THAT THE ACETABULAR COMPONENT WAS WELL FIXED TO THE UNDERLAYING BONE. IT HAD BEEN MEDIALIZED AND APPEARED TO BE PENETRATING THROUGH THE MEDIAL WALL ON THE X-RAYS. THE REMOVAL OF THIS COULD POTENTIALLY PLACE THE PATIENT AT RISK OF SEVERE BONE LOSS, SO IT WAS DECIDED TO LEAVE THE CUP IN PLACE. RESURFACING FEMORAL HEAD 42MM WAS REMOVED. S+N POLAR STEM 1 LATERAL, A 42 MM DUAL MOBILITY HEAD AND A 28+8 INNER HEAD WERE IMPLANTED. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Arthralgia; High metal ion levels; Pain

  MAUDE report 18681632 ↗
• InjuryAug 30, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A RIGHT BHR WAS PERFORMED ON THE (B)(6) 2006, THE PATIENT DEVELOPED PSEUDOTUMORS, THERE WAS LYSIS AROUND THE ACETABULAR CUP AND LOOSENING OF THE FEMORAL HEAD. A REVISION SURGERY WAS PERFORMED ON THE 08-NOV-2017 TO TREAT THIS ADVERSE EVENT. THE PATIENT RECEIVED A THA SYSTEM IN EXCHANGE.

  Patient problems: Metal Related Pathology; Osteolysis; Solid Tumor

  MAUDE report 17658635 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT BHR WAS PERFORMED ON THE (B)(6) 2008, THE PATIENT STARTED TO FEEL PAIN. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. THE PATIENT RECEIVED A THA SYSTEM IN EXCHANGE.

  Patient problems: Erosion; Osteolysis; Pain; Synovitis

  MAUDE report 17658138 ↗
• InjuryJun 8, 2023Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth; Biocompatibility; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT HIP RESURFACING (BHR) ON (B)(6) 2008 DUE TO HIP DYSPLASIA WITH OSTEOARTHRITIS AND CHRONIC HIP PAIN, THE PATIENT EXPERIENCED PAIN AND ELEVATED METAL IONS IN BLOOD. IN ADDITION, AN MRI REVEALED AN EDEMA IN THE SUBTROCHANTERIC REGION. THESE SYMPTOMS WERE ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022, IN WHICH BOTH RESURFACING COMPONENTS WERE EXPLANTED AND A COMPETITOR¿S THA CONSTRUCT (ZIMMER-BIOMET-J&J DEPUY) WAS PLACED IN EXCHANGE. DURING THIS PROCEDURE, THE BHR FEMORAL HEAD WAS NOTICED TO BE LOOSE. SURGERY WAS SUCCESSFULLY COMPLETED, AND THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO THE POST-ANESTHESIA CARE UNIT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; High metal ion levels; Joint effusion; Osteolysis

  MAUDE report 17092218 ↗
• InjuryMay 15, 2023Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER RIGHT HIP RESURFACING (BHR) WAS PERFORMED ON (B)(6) 2015 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED FEMORAL HEAD LOOSENING. THIS EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, IN WHICH EVEN THOUGH THE ACETABULAR CUP WAS WELL-FIXED, BOTH RESURFACING COMPONENTS WERE EXPLANTED, AND A COMPETITOR¿S HIP SYSTEM (DEPUY) WAS PLACED IN EXCHANGE. MINIMAL BONE LOSS WAS CAUSED WITH REMOVAL OF THE BHR ACETABULAR COMPONENT. INFERIOR AND POSTERIOR SPECIMENS WERE COLLECTED FROM THREE DIFFERENT SITES AND WERE SENT OFF FOR CULTURE; HOWEVER, TESTS RESULTS ARE NOT AVAILABLE AT THIS TIME. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16935744 ↗
• InjuryApr 26, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON LITERATURE REVIEW "BIRMINGHAM HIP RESURFACING FOR OSTEOARTHRITIS, A CANADIAN RETROSPECTIVE COHORT STUDY WITH A MINIMUM 10-YEAR FOLLOW-UP", AFTER A BHR RESURFACING SURGERY PERFORMED DUE TO OSTEOARTHRITIS, PATIENT EXPERIENCED AN ASEPTIC FEMORAL LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY 102 MONTHS AFTER IMPLANTATION. A CONVERSION FROM BHR RESURFACING TO A BHR THA WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16820471 ↗
• InjuryApr 25, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON LITERATURE REVIEW "HOW MUCH DOES A MEDICAL AND HEALTHCARE PRODUCTS REGULATORY AGENCY MEDICAL DEVICE ALERT FOR METAL-ON-METAL HIP ARTHROPLASTY PATIENTS REALLY COST?", ONE (1) PATIENT WAS CONFIRMED WITH ADVERSE REACTION TO METAL DEBRIS (ARMD) AND COBALT/CHROMIUM LEVELS AT 21,58 UG/L AND 29,14 UG/L RESPECTIVELY AFTER UNDERGOING A BHR RESURFACING PROCEDURE. THE EVENT WAS TREATED BY REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: High metal ion levels

  MAUDE report 16810904 ↗
• InjuryApr 25, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON LITERATURE REVIEW "HOW MUCH DOES A MEDICAL AND HEALTHCARE PRODUCTS REGULATORY AGENCY MEDICAL DEVICE ALERT FOR METAL-ON-METAL HIP ARTHROPLASTY PATIENTS REALLY COST?", ONE (1) PATIENT WAS CONFIRMED WITH ADVERSE REACTION TO METAL DEBRIS (ARMD) AND COBALT/CHROMIUM LEVELS AT 4,68 UG/L AND 11,33 UG/L RESPECTIVELY AFTER UNDERGOING A BHR RESUFACING PROCEDURE. THE EVENT WAS TREATED BY REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: High metal ion levels

  MAUDE report 16810568 ↗
• InjuryApr 25, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON LITERATURE REVIEW "HOW MUCH DOES A MEDICAL AND HEALTHCARE PRODUCTS REGULATORY AGENCY MEDICAL DEVICE ALERT FOR METAL-ON-METAL HIP ARTHROPLASTY PATIENTS REALLY COST?", ONE (1) PATIENT WAS CONFIRMED WITH ADVERSE REACTION TO METAL DEBRIS (ARMD) AND COBALT/CHROMIUM LEVELS AT 6,08 UG/L AND 8,79 UG/L RESPECTIVELY AFTER UNDERGOING A BHR RESUFACING PROCEDURE. THE EVENT WAS TREATED BY REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: High metal ion levels

  MAUDE report 16809415 ↗
• InjuryMar 13, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT HIP BHR PROCEDURE PERFORMED ON (B)(6) 2012, THE PLAINTIFF SUFFERED FROM ELEVATED METAL ION LEVELS IN BLOOD AND OCCASIONAL PLUNKING SENSATIONS IN THE LEFT HIP. NO REVISION SURGERY OR MEDICAL INTERVENTION HAS BEEN INDICATED AT THIS TIME TO ADDRESS THE ISSUE, HOWEVER, THE LEVEL OF COBALT IN BLOOD SUPPRESSES THE SAFETY LIMIT. THE CURRENT STATE OF HEATH OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; High metal ion levels

  MAUDE report 16527358 ↗
• InjuryAug 1, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING LEFT HIP BHR RESURFACING PROCEDURE DUE OSTEOARTHRITIS, THE PATIENT EXPERIENCED INCREASING PAIN IN THE LEFT HIP WITH SYSTEMIC MANIFESTATIONS OF METALLOSIS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, A LITTLE BIT OF BLACKENED DEBRIS WAS NOTED. THE RESURFACING FEMORAL HEAD WAS EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 15142085 ↗
• InjuryJul 28, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BIRMINGHAM HIP RESURFACING PROCEDURE ON (B)(6) 2006 DUE TO OSTEOARTHRITIS IN THE RIGHT HIP, THE PATIENT UNDERWENT A REVISION SURGERY TO A TOTAL HIP ARTHROPLASTY ON (B)(6) 2022. THE RESURFACING FEMORAL HEAD WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 15121155 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "METAL-ON-METAL HIP RESURFACING ARTHROPLASTY PROVIDES EXCELLENT LONG-TERM SURVIVORSHIP AND FUNCTION IN PATIENTS WITH A GOOD SIZED FEMORAL HEAD. 1 PATIENT SUFFERED FEMORAL NECK FRACTURE 4.7 YEARS AFTER A BHR AND REQUIRED A REVISION SURGERY. THERE'S NO MORE INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 14323344 ↗
• InjuryMay 6, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ON LITERATURE REVIEW "METAL-ON-METAL HIP RESURFACING ARTHROPLASTY PROVIDES EXCELLENT LONG-TERM SURVIVORSHIP AND FUNCTION IN PATIENTS WITH A GOOD SIZED FEMORAL HEAD.", 1 PATIENT SUFFERED FEMORAL COMPONENT LOOSENING 9 YEARS AFTER A BHR AND REQUIRED A REVISION SURGERY. THERE'S NO MORE INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14311960 ↗
• InjuryApr 13, 2022Biocompatibility; Biocompatibility

  US LEGAL: IT WAS REPORTED THAT, AFTER A LEFT BHR WAS PERFORMED ON (B)(6) 2007 DUE TO LEFT ARTHRITIS, THE PATIENT EXPERIENCED METALLOSIS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2020. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14102244 ↗
• InjuryApr 7, 2022Migration; Migration

  US LEGAL. IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A RIGHT HIP REVISION SURGERY ON (B)(6) 2020 DUE TO FEMORAL COMPONENT SUBSIDENCE. DURING THE REVISION SURGERY, ONLY THE BHR FEMORAL HEAD WAS EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PRIMARY BHR SURGERY WAS PERFORMED ON (B)(6) 2010.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 14047232 ↗
• InjuryApr 6, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S LEFT HIP ON (B)(6) 2007, THE PLAINTIFF EXPERIENCED ADVERSE LOCAL TISSUE REACTION ABUTTING THE EXTERNAL ILIAC VESSELS, ELEVATED METAL ION LEVELS, PAIN AND PSEUDOTUMOR FORMATION AROUND THE PELVIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE BHR RESURFACING FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH A DUAL MOBILITY LINER ¿ FULL THR SYSTEM. INTRAOPERATIVELY, A DECISION WAS MADE TO RETAIN THE CUP AS THERE WAS NO EVIDENCE OF ANY CORROSION. THE PLAINTIFF WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PLAINTIFF¿S OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 14027016 ↗
• InjuryApr 5, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S LEFT HIP ON (B)(6) 2009, THE PLAINTIFF EXPERIENCED PAIN, WEAKNESS, TRENDELENBURG GAIT, ELEVATED CHROMIUM AND COBALT ION LEVELS IN BLOOD AND FLUID WITH INFLAMMATION OF THE CAPSULE DUE TO ADVERSE REACTION TO METAL DEBRIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE RESURFACING FEMORAL HEAD 42M WAS REMOVED AND REPLACED WITH A TOTAL HIP ARTHROPLASTY CONSTRUCT. THE BHR ACETABULAR CUP WAS WELL FIXED AND POSITIONED ON THE PATIENT¿S ACETABULUM; THEREFORE, IT WAS NOT EXPLANTED. THE PATIENT WAS TRANSFERRED TO THE PACU ROOM IN STABLE CONDITION.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Metal Related Pathology

  MAUDE report 14007886 ↗
• InjuryApr 5, 2022Biocompatibility; Biocompatibility

  US LEGAL MDL. IT WAS REPORTED THAT, AFTER PRIMARY LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED PAIN AND METALLOSIS. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2020. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14007806 ↗
• InjuryMar 23, 2022Biocompatibility; Biocompatibility

  US LEGAL: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2021 DUE TO PAIN, LIMITED MOBILITY, AND ELEVATED METAL ION LEVELS. THE PRIMARY LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2008. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Infiltration into Tissue; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 13865257 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040033. One submission often covers many models, so check the product and lot details in each record.

• Z-2242-2021 · Jul 14, 2021 · Terminated
  smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
• Z-2268-2018 · May 11, 2018 · Terminated
  Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Siz
• Z-2267-2018 · May 11, 2018 · Terminated
  Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156
• Z-2746-2015 · Jun 3, 2015 · Terminated
  Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74
• Z-2747-2015 · Jun 3, 2015 · Terminated
  Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Pro
• Z-2745-2015 · Jun 3, 2015 · Terminated
  Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 M
• Z-0028-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component.
• Z-0029-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0026-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component.
• Z-0032-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component.
• Z-0031-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. Hip implant component.
• Z-0017-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component.
• Z-0024-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component.
• Z-0022-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component.
• Z-0025-2008 · Jul 12, 2007 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant component.

…and 14 more.